The COVID-19 vaccine (Recombinant protein, Adjuvanted) belongs to a group of medication known as vaccines. It is used to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 12 years of age and older.

The COVID-19 vaccine (Recombinant protein, Adjuvanted) increases a person's defenses against the SARS-CoV-2 virus by introducing protein fragments that look like the spike protein of the virus. This protein triggers the body to produce antibodies, cells that are designed to attack the virus in the body. The antibodies stay in your body, ready to attack future SARS-CoV-2 virus that enters the body. The vaccine does not contain the actual virus and cannot give you COVID-19.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of this vaccine is 0.5 mL injected intramuscularly (into the muscle) and then a second dose given the same way 3 weeks after the first dose.

Adults 18 years of age and older may be given a booster dose of this vaccine 6 months after the second dose of vaccine.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive COVID-19 Recombinant vaccine, contact your doctor as soon as possible to reschedule your appointment. This medication may be given by a health care professional in a doctor's office or clinic.

Each 0.5 mL dose contains 5 mg of SARS-CoV-2 recombinant spike protein (original [Wuhan] strain) and 50 mg of Matrix-M adjuvant (Quillaja saponaria saponins fraction-A and fraction-C). Nonmedicinal ingredients: disodium hydrogen phosphate heptahydrate, hydrochloric acid (for pH adjustment), polysorbate 80, sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydroxide (for pH adjustment), and water for injection; adjuvant:  cholesterol, disodium hydrogen phosphate dihydrate, phosphatidylcholine, potassium chloride, potassium dihydrogen phosphate, and sodium chloride.

Do not take this medication if you are allergic to SARS-CoV-2 virus or any ingredients of this medication or container.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• chills
• fatigue
• fever
• general feeling of being unwell
• headache
• joint pain
• muscle aches
• nausea
• numbness or decreased sense of touch
• pain, redness, or swelling at the injection site
• tingling, itching, or prickling sensation
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Stop taking the medication and seek immediate medical attention if any of the following occur:

• pain in the arm, hand, leg, or foot
• signs of an allergic reaction (e.g., difficulty breathing, hives, skin rash, swelling of the face or throat)
• symptoms of inflammation of tissue surrounding the heart (pericarditis; e.g., chest pain, cough, fast or irregular heartbeat, shortness of breath, weakness or fatigue)
• symptoms of inflammation of the heart muscle (myocarditis; e.g., chest pain, swelling of the feet and legs; fast or irregular heartbeat, shortness of breath, joint stiffness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Rarely, this vaccine may cause severe allergic reactions. For this reason, doctors often ask you to stay in the office for about 30 minutes after having the vaccine so that you can get medical care if you have an allergic reaction. If you notice the signs of a severe allergic reaction (hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get medical attention immediately.

Bleeding disorders and anticlotting medications: People with bleeding disorders and people taking medications that affect blood clotting may be at an increased risk for bleeding. Talk to your doctor if this is a concern for you.

Fainting: As with other injectable vaccines, this vaccine may cause fainting. If you notice signs such as dizziness, changes in heart rate, shortness of breath, tingling sensations or sweating, get medical attention immediately.

Immune system: As with any vaccine, this vaccine may not be as effective for people with a weakened immune system (such as those on chemotherapy, people who have had an organ transplant, or people with HIV). If you are taking any medications that suppress your immune system, you may have to wait until treatment has stopped before receiving this vaccine. Talk to your doctor.

Myocarditis and pericarditis: Rarely, cases of inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), have occurred in people who have received this vaccine. If you experience symptoms such as chest pain, shortness of breath, or feelings of a fast, fluttering or pounding heartbeat within a few days of vaccination, get medical attention immediately.

Other illness: If you have a high fever or other illness, talk to your doctor about rescheduling your appointment to receive this vaccine after you have recovered. It is advisable to wait to receive this vaccine if you have an acute, severe illness with fever.

Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it.

Pregnancy: If you are pregnant, talk to your doctor about the risks and benefits of receiving this vaccine.

Breast-feeding: It is not known if this vaccine passes into breast milk. If you are breast-feeding, this medication may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this vaccine has not been established for children less than 12 years of age.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.